Pediatric blood & cancer · 2026
Intravenous Fosaprepitant Versus Oral Aprepitant for Children Receiving Highly Emetogenic Chemotherapy: An Investigator-Initiated Randomized, Open-Label, Non-Inferiority Trial.
СтатьяРандомизированное исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Rasheed Azgar Abdul, Ganguly Shuvadeep, Sra Manraj Singh, Kumar Santhosh, Batra Atul, Pushpam Deepam, Vishnubhatla Sreenivas, Pillai Ashwati S, Joison Anu Theresa, Sharma Swetambri, Bakhshi Sameer
Аннотация
BACKGROUND: Fosaprepitant is non-inferior to aprepitant in adults receiving highly emetogenic chemotherapy (HEC). We evaluated whether fosaprepitant is non-inferior to aprepitant in children receiving HEC.
METHODS: In this open-label, non-inferiority trial, children aged 5-18 years, receiving their first cycle of HEC, were randomized 1:1 to the fosaprepitant or aprepitant group. The fosaprepitant group received a single intravenous dose of 4 mg/kg (max 150 mg). The aprepitant group received oral aprepitant capsules (weight 15 to <30 kg: 80 mg Days 1-3; weight ≥30 kg, or age ≥12 years: 125 mg Day 1, 80 mg Days 2 and 3). Both groups received ondansetron and dexamethasone. The primary outcome was the complete response (CR) rate of vomiting during the acute phase (AP) with a non-inferiority margin of 15%. Secondary outcomes included CR rates in the delayed (DP) and overall phases (OP), grade of vomiting, incidence and severity of nausea, and adverse effects.
RESULTS: A total of 279 children were included in the modified intention-to-treat analysis (fosaprepitant group: 140; aprepitant group: 139). In AP, the difference of CR rate between fosaprepitant [76 (54.3%)] and aprepitant groups [84 (60.4%)] was -6.1% [90% CI: -15.7% to +3.6%], with the lower limit exceeding -15%, failing to establish non-inferiority. The CR rate with fosaprepitant versus aprepitant was 62.1% (n = 87) versus 65.5% (n = 91) in DP (difference: -3.4%; 90% CI: -12.7% to 6.1%) and 42.9% (n = 60) versus 49.6% (n = 69) in the OP (difference: -6.7%; 90% CI: -16.5% to 3.1%). Grade of vomiting, incidence and severity of nausea, and adverse effects were similar between the two groups.
CONCLUSIONS: Non-inferiority of fosaprepitant compared to aprepitant was not demonstrated in children undergoing their first cycle of HEC.
TRIAL REGISTRATION: Clinical Trials Registry, India (CTRI/2019/05/019082).
METHODS: In this open-label, non-inferiority trial, children aged 5-18 years, receiving their first cycle of HEC, were randomized 1:1 to the fosaprepitant or aprepitant group. The fosaprepitant group received a single intravenous dose of 4 mg/kg (max 150 mg). The aprepitant group received oral aprepitant capsules (weight 15 to <30 kg: 80 mg Days 1-3; weight ≥30 kg, or age ≥12 years: 125 mg Day 1, 80 mg Days 2 and 3). Both groups received ondansetron and dexamethasone. The primary outcome was the complete response (CR) rate of vomiting during the acute phase (AP) with a non-inferiority margin of 15%. Secondary outcomes included CR rates in the delayed (DP) and overall phases (OP), grade of vomiting, incidence and severity of nausea, and adverse effects.
RESULTS: A total of 279 children were included in the modified intention-to-treat analysis (fosaprepitant group: 140; aprepitant group: 139). In AP, the difference of CR rate between fosaprepitant [76 (54.3%)] and aprepitant groups [84 (60.4%)] was -6.1% [90% CI: -15.7% to +3.6%], with the lower limit exceeding -15%, failing to establish non-inferiority. The CR rate with fosaprepitant versus aprepitant was 62.1% (n = 87) versus 65.5% (n = 91) in DP (difference: -3.4%; 90% CI: -12.7% to 6.1%) and 42.9% (n = 60) versus 49.6% (n = 69) in the OP (difference: -6.7%; 90% CI: -16.5% to 3.1%). Grade of vomiting, incidence and severity of nausea, and adverse effects were similar between the two groups.
CONCLUSIONS: Non-inferiority of fosaprepitant compared to aprepitant was not demonstrated in children undergoing their first cycle of HEC.
TRIAL REGISTRATION: Clinical Trials Registry, India (CTRI/2019/05/019082).